Lynne Yao
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View article: Paediatric developmental safety and the ICH E11A extrapolation of safety
Paediatric developmental safety and the ICH E11A extrapolation of safety Open
View article: Case Series and Literature Review on Tofacitinib for Treating Severe Alopecia Areata
Case Series and Literature Review on Tofacitinib for Treating Severe Alopecia Areata Open
This study supports the efficacy and safety of tofacitinib in AA treatment, providing further clinical evidence for its application.
View article: Pediatric Developmental Safety and the Extrapolation of Safety
Pediatric Developmental Safety and the Extrapolation of Safety Open
View article: Considerations for the Treatment Strategy of Relapse After Tofacitinib Therapy in Alopecia Areata
Considerations for the Treatment Strategy of Relapse After Tofacitinib Therapy in Alopecia Areata Open
Background Alopecia areata (AA) is an autoimmune disorder mediated by T cells, resulting in hair loss on the scalp, eyebrows, and body. Conventional treatments for AA often exhibit high recurrence rates and various side effects. Recently, …
View article: Enhancing inclusivity in clinical trials: Model‐informed drug development for pregnant individuals in the era of personalized medicine
Enhancing inclusivity in clinical trials: Model‐informed drug development for pregnant individuals in the era of personalized medicine Open
The underrepresentation of pregnant individuals in clinical trials and drug development programs causes a lack of safety and efficacy data for this population and poses a significant public health challenge. This article outlines various s…
View article: Pharmacokinetic Evaluation in Pregnancy—Current Status and Future Considerations: Workshop Summary
Pharmacokinetic Evaluation in Pregnancy—Current Status and Future Considerations: Workshop Summary Open
As pregnant individuals have traditionally been excluded from clinical trials, there is a gap in knowledge at the time of drug approval regarding safety, efficacy, and appropriate dosing for most prescription medications used during pregna…
View article: Therapeutic Development in Polyarticular Course Juvenile Idiopathic Arthritis: Extrapolation, Dose Selection, and Clinical Trial Design
Therapeutic Development in Polyarticular Course Juvenile Idiopathic Arthritis: Extrapolation, Dose Selection, and Clinical Trial Design Open
Objective Stakeholders met to address persistent challenges facing the development of therapeutics for polyarticular juvenile idiopathic arthritis (pJIA), which result in fewer approved therapies for children with pJIA than adults with rhe…
View article: Overcoming Barriers to Drug Development in Children with CKD
Overcoming Barriers to Drug Development in Children with CKD Open
Like all sick children, children with CKD need access to safe and effective medicines that have been formulated and examined specifically for them. Despite legislation in the United States and the European Union that either mandates or inc…
View article: A Comparison of <scp>FDA</scp> and <scp>EMA</scp> Pregnancy and Lactation Labeling
A Comparison of <span>FDA</span> and <span>EMA</span> Pregnancy and Lactation Labeling Open
The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have robust collaboration and dialogue around the need for data and the inclusion of pregnant and lactating individuals in clinical trials. Despite this coll…
View article: A review of pregnancy and lactation postmarketing studies required by the <scp>FDA</scp>
A review of pregnancy and lactation postmarketing studies required by the <span>FDA</span> Open
Since pregnant and lactating women have historically been excluded from drug development trials, safety studies need to be conducted postapproval. This study evaluated FDA's Post Marketing Requirements for pregnancy and lactation studies f…
View article: Considerations and Challenges in the Remdesivir COVID‐19 Pediatric Development Program
Considerations and Challenges in the Remdesivir COVID‐19 Pediatric Development Program Open
The US Food and Drug Administration is committed to the development of effective antiviral regimens for pediatric patients with coronavirus disease 2019 (COVID‐19), including infants and neonates. On April 25, 2022, the approved indication…
View article: Innovations in Pediatric Therapeutics Development: Principles for the Use of Bridging Biomarkers in Pediatric Extrapolation
Innovations in Pediatric Therapeutics Development: Principles for the Use of Bridging Biomarkers in Pediatric Extrapolation Open
Even with recent substantive improvements in health care in pediatric populations, considerable need remains for additional safe and effective interventions for the prevention and treatment of diseases in children. The approval of prescrip…
View article: The safety of asthma medications during pregnancy and lactation: Clinical management and research priorities
The safety of asthma medications during pregnancy and lactation: Clinical management and research priorities Open
View article: Assuring Access to Safe Medicines in Pregnancy and Breastfeeding
Assuring Access to Safe Medicines in Pregnancy and Breastfeeding Open
Scientists and regulators in Europe and the United States continue to seek methods and strategies to improve knowledge on rational use of medicines for pregnant and breastfeeding populations, an important subset of women’s health. Regulato…
View article: Issue Information
Issue Information Open
Aims and Scope: For more than 50 years, clinical pharmacologists, clinical and pharmaceutical researchers, drug development specialists, physicians, nurses, and other medical professionals have relied on The Journal of Clinical Pharmacolog…
View article: Expanding research to provide an evidence base for nutritional interventions for the management of inborn errors of metabolism
Expanding research to provide an evidence base for nutritional interventions for the management of inborn errors of metabolism Open
A trans-National Institutes of Health initiative, Nutrition and Dietary Supplement Interventions for Inborn Errors of Metabolism (NDSI-IEM), was launched in 2010 to identify gaps in knowledge regarding the safety and utility of nutritional…
View article: Creatinine‐Based Renal Function Assessment in Pediatric Drug Development: An Analysis Using Clinical Data for Renally Eliminated Drugs
Creatinine‐Based Renal Function Assessment in Pediatric Drug Development: An Analysis Using Clinical Data for Renally Eliminated Drugs Open
The estimated glomerular filtration rate (eGFR) equations based on serum creatinine (SCR) have been used for pediatric dose adjustment in drug labeling. This study evaluated the performance of those equations in estimating individual clear…
View article: Combined Pediatric and Adult Trials Submitted to the US Food and Drug Administration 2012–2018
Combined Pediatric and Adult Trials Submitted to the US Food and Drug Administration 2012–2018 Open
Despite legislation incentivizing and requiring drug companies to conduct pediatric clinical trials, there still is a 9‐year delay in drug approval for pediatric labeling after the initial adult drug approval. The aim of this study was to …
View article: Neonatal Safety Information Reported to the FDA During Drug Development Studies
Neonatal Safety Information Reported to the FDA During Drug Development Studies Open
Relatively few neonatal drug development studies have been conducted, but an increase is expected with the enactment of the Food and Drug Administration Safety and Innovation Act (FDASIA). Understanding the safety of drugs studied in neona…
View article: Exposure Matching for Extrapolation of Efficacy in Pediatric Drug Development: Extrapolation of Efficacy in Pediatric Drug Development
Exposure Matching for Extrapolation of Efficacy in Pediatric Drug Development: Extrapolation of Efficacy in Pediatric Drug Development Open
During drug development, matching adult systemic exposures of drugs is a common approach for dose selection in pediatric patients when efficacy is partially or fully extrapolated. This is a systematic review of approaches used for matching…
View article: Pediatric Extrapolation in Type 2 Diabetes: Future Implications of a Workshop
Pediatric Extrapolation in Type 2 Diabetes: Future Implications of a Workshop Open
Extrapolation from adults to youth with type 2 diabetes (T2D) is challenged by differences in disease progression and manifestation. This manuscript presents the results of a mock‐team workshop focused on examining the typical team‐based d…
View article: Scientific and Regulatory Considerations for an Ontogeny Knowledge Base for Pediatric Clinical Pharmacology
Scientific and Regulatory Considerations for an Ontogeny Knowledge Base for Pediatric Clinical Pharmacology Open
Understanding all aspects of developmental biology, or pediatric ontogeny, that affect drug therapy from the fetus to the adolescent child is the holy grail of pediatric scientists and clinical pharmacologists. The scientific community is …
View article: Renal Clearance in Newborns and Infants: Predictive Performance of Population‐Based Modeling for Drug Development
Renal Clearance in Newborns and Infants: Predictive Performance of Population‐Based Modeling for Drug Development Open
The objective of this study was to evaluate the predictive performance of population models to predict renal clearance in newborns and infants. Pharmacokinetic (PK) data from eight drugs in 788 newborns and infants were used to evaluate th…
View article: Paediatric extrapolation: A necessary paradigm shift
Paediatric extrapolation: A necessary paradigm shift Open
Legislative initiatives have been successful in increasing the availability of approved therapies for paediatric patients. However, additional measures to ensure the timely completion of paediatric studies are necessary to further increase…
View article: Primary Endpoints in Pediatric Efficacy Trials Submitted to the US FDA
Primary Endpoints in Pediatric Efficacy Trials Submitted to the US FDA Open
The selection of appropriate endpoints in pediatric drug development trials is a critical aspect of trial design. Given the high pediatric trial failure rate, selecting optimal trial design elements, such as the primary efficacy endpoint, …
View article: Enrichment Strategies in Pediatric Drug Development: An Analysis of Trials Submitted to the US Food and Drug Administration
Enrichment Strategies in Pediatric Drug Development: An Analysis of Trials Submitted to the US Food and Drug Administration Open
Clinical trial enrichment involves prospectively incorporating trial design elements that increase the probability of detecting a treatment effect. The use of enrichment strategies in pediatric drug development has not been systematically …
View article: Development of Drug Therapies for Newborns and Children
Development of Drug Therapies for Newborns and Children Open
View article: Enhancing clinical trial development for pediatric kidney diseases
Enhancing clinical trial development for pediatric kidney diseases Open
View article: Neonatal Safety Information Reported to the FDA During Drug Development Studies
Neonatal Safety Information Reported to the FDA During Drug Development Studies Open
View article: Pediatric Medicine Development: An Overview and Comparison of Regulatory Processes in the European Union and United States
Pediatric Medicine Development: An Overview and Comparison of Regulatory Processes in the European Union and United States Open